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Информационен център на ЕС за нормативни изисквания за медицински изделия

Тук ще намерите някои важни документи, които ще ви помогнат при кандидатстването за сертифициране по новия Регламент за медицинските изделия и Регламента за медицинските изделия за ин витро диагностика.

Справочни документи

MDR Unannounced Audit Questionnaire

Medical Device Questionnaire

Medical Device Regulation (MDR) Conformity Assessment Explained

Medical Device Regulation (MDR) Readiness Checklist

Medical Device Regulation (MDR) Technical Documentation Request Form

Medical Devices Notification of Changes, Regulatory Action, Consultancy or Services Rendered

Medical Devices Pre-Audit Client Questionnaire

Notified Body Managers' Declaration of Interest

SGS MDR Transition Plan Template

Product Medical Device Questionnaire

Relevant Subcontractors and Suppliers List

Transition Guidance for SGS Customers

Външни документи

EUDAMED - Actor Registration Factsheet

Factsheet for Manufacturers of In Vitro Diagnostic Medical Devices

Factsheet for Manufacturers of Medical Devices

Factsheet - Medical Devices and in vitro Diagnostic Medical Devices (For Authorised Representatives, Importers and Distributors)

Factsheet on Medical Devices and in vitro Diagnostic Medical Devices (For non-EU/EEA States)

Guidance for Actor Registration Module in EUDAMED (V1 -Sept. 2020)

Implementation for Medical Devices Regulation (Focus on Manufacturer’s obligations)

Implementation Model for In-Vitro Diagnostic Medical Devices Regulation

Implementation Model for Medical Devices Regulation

MDR IVDR Infographic

Transition Timelines from the Directives to the Regulations

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